Status:
RECRUITING
A Research Study to See How Well Weekly Insulin Icodec Maintains Blood Sugar Levels Compared to Daily Basal Insulins in Adults With Type 2 Diabetes
Lead Sponsor:
Novo Nordisk A/S
Conditions:
Diabetes Mellitus, Type 2
Eligibility:
All Genders
18+ years
Phase:
PHASE4
Brief Summary
This study compares insulin icodec, taken once a week, with other basal insulins, taken once a day, in people with type 2 diabetes.The purpose of this study is to see how well the approved injectable ...
Eligibility Criteria
Inclusion Criteria:
- Diagnosed with T2D greater than or equal to (≥) 180 days prior to the day of screening.
- Treatment with any of the following non-insulin glucose-lowering medication(s) or combination regimen(s) at the time of screening:
Metformin, Sulfonylureas, Meglitinides (glinides), dipeptidyl peptidase-4 (DPP-4) inhibitors, sodium-glucose cotransporter-2 (SGLT2) inhibitors, Thiazolidinediones, Alpha-glucosidase inhibitors, Oral combination products (for the allowed individual oral antidiabetic drugs), Oral or injectable glucagon-like peptide-1 (GLP-1) receptor agonists and Injectable dual glucose-dependent insulinotropic polypeptides (GIP) and GLP-1 receptor agonist.
- Need of intensification with basal insulin, as indicated at the discretion of the investigator.
- Recorded HbA1c value ≥7% within the last 90 days prior to randomization.
Exclusion Criteria:
- Known or suspected hypersensitivity to study intervention(s) or related products.
- Previous participation in this study. Participation is defined as signed informed consent.
- Female who is pregnant, breast-feeding or intends to become pregnant or is of child-bearing potential and not using adequate contraceptive method.
- Participation (i.e., received any study intervention) in any interventional clinical study within 90 days before screening.
- Any disorder which in the investigator's opinion might jeopardize participant's safety.
Key Trial Info
Start Date :
August 15 2025
Trial Type :
INTERVENTIONAL
Allocation :
ESTIMATED
End Date :
August 31 2028
Estimated Enrollment :
586 Patients enrolled
Trial Details
Trial ID
NCT07112339
Start Date
August 15 2025
End Date
August 31 2028
Last Update
April 6 2026
Active Locations (75)
Enter a location and click search to find clinical trials sorted by distance.
1
Centricity Research Calgary Endocrinology
Calgary, Alberta, Canada, T2H 2G4
2
Alta Clinical Research at Hermitage Medicentre
Edmonton, Alberta, Canada, T5A 4L8
3
Fraser Clinical Trials Inc.
New Westminster, British Columbia, Canada, V3L 3W4
4
Winnipeg Clinic
Winnipeg, Manitoba, Canada, R3C 0N2